The exploratory study about the neurophysiological index which predicts the effect of the methylphenidate hydrochloride in children with AD/HD

UMIN ID: UMIN000001270

Registered date:01/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Attention deficit hyperactivity disorder
• Date of first enrollment: 2008/08/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

MPH (one day) => washout (1week) => placebo (one day) => MPH (4-8-weeks) => 1-y continuous administration of MPH (drug naive ADHD group)(as an ancillary study)
placebo (one day)=> washout (1week) => MPH (one day) => MPH (4-8-weeks) => 1-y continuous administration of MPH (drug naive ADHD group)(as an ancillary study)

Outcome(s)

• Primary Outcome: 1) Whether an NIRS signal taken before drug administration can predict the effect of the drug after continuous administration (CGI-S) in the drug naive ADHD group (Part A + Part C). 2) Whether the change in the NIRS signal from a baseline measurement to a measurement taken after a single dose can predict drug efficacy after 4-8 weeks of continuous administration (CGI-S) in the drug naive ADHD group (Part A, Part B, Part C).
• Secondary Outcome: 1) The effect of a single dose of the true drug and a placebo on NIRS signals (Part B). 2) The effect of continuous administration of the drug on NIRS signals (Part C). 3) The differences in NIRS signals (baseline, single dose, after continuous administration) between the drug naive ADHD group and the ADHD group with treatment history (Part A, Part B, Part C). 4) Whether the change in the NIRS signal from a baseline measurement to a measurement taken after a single dose can predict drug efficacy after 1 year of continuous administration (CGI-S) in the drug naive ADHD group (Part A, Part B, Part D). 5) Changes in the NIRS signal in the drug naive ADHD group after a washout period after 1 year of continuous administration (Part A, Part D). 6) The relationship between changes in frontal lobe functions and genetic polymorphisms (Part A, Part B, Part C, Part D).

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 13years-old
• Gender: Male and Female
• Exclude criteria: 1.A child who is judged that he/she cannot obey and understand the instruction of this trial by the investigator. 2.A child who weighs under 20kg. 3.A child who is diagnosed now with critical undesirable diseases to this trial. 4.A child who has abnormalin the examination of 12-lead electrocardiogram. 5.A child who has abnormal blood pressure. 6.A child who is judged by the investigator or subinvestigator of this trial that he/she has inadequate score in clinical examination. 7.A child who is diagnosed now with glaucoma, thyroidal dysfunction or epilepsia, or has a previous history of those diseases. 8.A child who is diagnosed now with a motor tic, or the Tourette's syndrome or has a previous or first-degree family history of Tourette's syndrome. 9.A child who has a depression that needed a prompt medical treatment of them. 10.A child who is diagnosed as his/her main disorder with an oppositional defiant disorder, conduct disorder. 11.A child who is judged that he/she cannot obey and/or understand the instruction of this trial because he/she has both an impaired coordination and a learning disability. 12.A child who has a full IQ score calculated by WISC-3 less than 70 points. , 13.A child who starts a training program after the day of IC acquisition or finishes it before the end of this trial. 14.The child who has taken the medicine in the dosage exceeding a 60mg/day MPH now. 15.A child whom hypersensitivity to MPH was shown. Or a child who was judged to have serious side-effects of MPH. 16.A child who takes a medicine that combination is prohibited or he/she is judged to need to take it within 7 days before the first day of the behavioral assessment. 17.The child who has drug abuse, drug intoxication, alcoholism, or first-degree family history of those diseases 18.A girl who has her first menstrual period before the start of this trial.

Related Information

• Primary Sponsor: University of Tokyo Medical School The department of Psychiatry
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare.Health and Labour Sciences Research Grants.Research on Psychiatric and Neurological Diseases and Mental Health.(H17-kokoro-004)
• Secondary ID(s): P2007009